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A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and Sulindac (PACES)

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Prevention
NCT ID
NCT01349881
Protocol IDs
S0820 (primary)
U10CA037429
NCI-2012-02067
Study Sponsor
Southwest Oncology Group

Summary

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer.

Objectives

The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Northeast Georgia Medical Center - Gainesville


NGMC-Gainesville
Wisteria Building Suite 420
200 South Enota
Gainesville, GA 30501
770-219-8822
www.nghs.com

Study Coordinator:
Trena Davis BSN, RN, CRCC
770-219-8822

Doctors:

Andre M. Kallab MD
Richard J. LoCicero MD
Padma C. Nadella MD
Charles H. Nash, III MD, FACP
Geoffrey J. Weidner MD
Saloni H. Tanna MD
Christina A. Saurel MD

Piedmont Columbus Regional


1831 5th Ave
Columbus, GA 31901
www.columbusregional.com

Study Coordinator:
Jay Pitts, BS, CPhT
706-596-5426

Doctors:

Wilbur B. Bassett, Jr. MD
Andrew W. Pippas MD
Peter Q. Jiang MD
Suresh Nukala MD

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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